Universal Disinfection Cap

Abstract

To solve a problem that it is likely for a conventional holding clip to increase necessary force up to an undesirable extent so as to unlock a hold mechanism.SOLUTION: A device is for connection to a medical connector, and the device includes a cap body, a coupling cylinder adapted to engage a male luer connector and a female luer connector, a bulb compartment filled with air, a reagent compartment filled with a disinfectant or an antimicrobial reagent, and a passageway connecting the bulb compartment to the reagent compartment. The reagent compartment includes an exterior wall surface, an interior wall surface, an array of resealable pores densely integrated throughout the exterior wall surface and the interior wall surface of the reagent compartment, and a distal tip. The passageway may be positioned in an aperture of a proximal wall of the cap body. The coupling cylinder may include an O-ring.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates generally to devices for disinfecting and sterilizing access ports, for example, with male and female Luer fittings, and more particularly to a disinfection and sterilization device that can accommodate multiple types of connectors. [Background technology]

[0002] Vascular access devices (VAD's) are commonly used therapeutic devices and include intravenous (IV) catheters. There are two general classifications of VAD's: peripheral catheters and central venous catheters. Bacteria and other microorganisms can enter a patient's vascular system through an access hub, port, or valve upon connection to a VAD to deliver fluids or medications. Each access hub, port, or valve connection is associated with some risk of transmitting a catheter-related bloodstream infection (CRBSI), which can be costly and potentially fatal.

[0003] To reduce cases of catheter-related bloodstream infections (CRBSI) and to ensure that VADs are used and maintained correctly, standards of practice have been developed, including disinfection and cleaning procedures.

[0004] Antiseptic caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines, and early indications are that the caps will also be incorporated into the Infusion Nurses Standards (INS) guidelines.

[0005] In developed markets, when utilizing IV catheters, needleless connectors are typically used to close the system and then access the patient to administer medications or other necessary fluids via the catheter. INS practice standards recommend the use of needleless connectors and state that they should be "consistently and thoroughly disinfected with alcohol, tincture of iodine, or a combination of chlorhexidine gluconate / alcohol prior to each access." Disinfection of needleless connectors is ultimately intended to aid in the reduction of bacteria that can live on surfaces and cause a variety of catheter-related complications, including the previously mentioned CRBSI cases. Nurses typically utilize 70% IPA alcohol pads to complete this disinfection task, performing what is known as "scrubbing the hub." However, compliance with this practice is typically very low. In addition to the lack of compliance with "scrubbing the hub," it was also noted through clinician interviews that there is often variability in scrubbing time, drying time, and the number of times needleless connectors are scrubbed.

[0006] There are many risks of contact or contamination throughout the sequence of steps associated with the transmission of microorganisms that can cause CRBSI. Contamination can occur during mixing of drugs, attachment of the cannula, and insertion into the access hub. Because the procedure for connecting to a VAD is so common and simple, the risks associated with entry into the patient's vascular system are often overlooked. Currently, the risk to the hospital and the patient is a substantial function of the diligence of the clinician making the connection, and this diligence is largely uncontrollable.

[0007] Currently, antiseptic caps on the market are capable of disinfecting only one of three types of luer fittings: female luer on needleless connectors, female luer on stopcocks, and male luer connectors on intravenous infusion sites. Currently, caps for male needleless connectors, female needleless connectors, intravenous (IV) and hemodialysis lines use different designs, which limits the type of connector to which the caps can be attached. Conventional antiseptic caps are designed to fit only one type of connector and are specific to one particular size and / or shape of connector. Although certain antiseptic caps currently on the market are generally intended for use with closed female luer on needleless connectors that can also fit open female luer on stopcocks, antiseptic caps currently on the market are unable to disinfect the lumen of stopcocks. While antiseptic caps currently on the market disinfect the lumen of open female luer, they are unable to couple to both male and female connectors. That is, there is a need for a antiseptic device that can accommodate multiple types of connectors, including both male and female connectors, to streamline the antiseptic process. Summary of the Invention

[0008] One aspect of the present disclosure relates to a device for connecting to a medical connector. According to a second exemplary embodiment of the present disclosure, the device generally comprises a cap body, a coupling cylinder, a valve compartment, a reagent compartment, and a passageway connecting the valve compartment to the reagent compartment. The cap body includes a sidewall having an outer surface and an inner surface, an open distal end, and a proximal end. The proximal end includes a proximal wall having an opening. The sidewall has a length L extending from the proximal end to the open distal end. O1 The open end defines an end face.

[0009] In one or more embodiments, the coupling cylinder includes a sidewall with an inner surface that mates with the external threaded surface of the female connector or hemodialysis connector, an outer surface that mates with the threaded surface of the collar of the male connector, a distal end, and a proximal end.

[0010] In one or more embodiments, the valve compartment is filled with air.

[0011] The reagent compartment defines a chamber containing a disinfectant or antimicrobial agent. The reagent compartment includes an outer wall surface, an inner wall surface, an array of resealable pores tightly integrated into the outer and inner wall surfaces of the reagent compartment, and a distal tip.

[0012] In one or more embodiments, the passageway is disposed in an opening in the proximal wall.

[0013] In one or more embodiments, the distal end of the coupling cylinder includes an O-ring. In one or more embodiments, the O-ring is made of an elastomeric material.

[0014] In one or more embodiments, the open distal end of the cap body is positioned approximately on the same horizontal plane P as the distal tip of the reagent compartment or less than 8 mm away from the open distal end of the cap body in an initial state, such that when the female or male Luer connector engages the device, the reagent compartment is compressed and retracts toward the proximal wall.

[0015] In one or more embodiments, compression of the chamber releases a disinfectant or antimicrobial agent from the reagent compartment to disinfect the female or male Luer connector. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzalkonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

[0016] In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or gel.

[0017] In one or more embodiments, the female luer connector is selected from the group comprising essentially a needleless connector, a stopcock, and a hemodialysis connector.

[0018] In one or more embodiments, the male connector is an intravenous tubing end or a stopcock.

[0019] In one or more embodiments, the device further includes a peelable seal at the open end of the cap body.

[0020] In one or more embodiments, the peelable seal may include an aluminum or multi-layer polymer film peel back top.

[0021] According to a second exemplary embodiment of the present disclosure, a device generally comprises a cap body, a coupling cylinder, a valve compartment, a reagent compartment, and a passageway connecting the valve compartment to the reagent compartment. The cap body includes a sidewall having an outer surface and an inner surface, an open distal end, and a proximal end. The proximal end includes a proximal wall having an opening. The sidewall has a length LO1 extending from the proximal end to the open distal end. The open end defines an end face.

[0022] In one or more embodiments, the coupling cylinder includes a sidewall with an inner surface that mates with the outer threaded surface of the female connector or hemodialysis connector, an outer surface that mates with the threaded surface of the collar of the male connector, a distal end, and a proximal end. The coupling cylinder may be made of a semi-rigid material such as a thermoplastic elastomer (TPE), a polypropylene (PP) / thermoplastic elastomer (TPE) blend, or a polyethylene (PE) / thermoplastic elastomer (TPE) blend with a layer of a thermoplastic elastomer (TPE) coat or other mixture of plastic and thermoplastic elastomer, thermoplastic elastomer (TPE), or rubber of similar elasticity, or a polypropylene (PP) / polyethylene (PE) material. In one or more embodiments, the coupling cylinder may be made using a two-shot molding process.

[0023] In one or more embodiments, the valve compartment is filled with air.

[0024] The reagent compartment defines a chamber containing a disinfectant or antimicrobial agent. The reagent compartment includes an outer wall surface, an inner wall surface, an array of resealable pores tightly integrated into the outer and inner wall surfaces of the reagent compartment, and a distal tip.

[0025] In one or more embodiments, the passageway is disposed in an opening in the proximal wall.

[0026] In one or more embodiments, the distal end of the coupling cylinder includes an O-ring. In one or more embodiments, the O-ring is made of an elastomeric material.

[0027] In one or more embodiments, the side wall of the coupling cylinder includes one or more leaf springs.

[0028] In one or more embodiments, the open distal end of the cap body is positioned approximately on the same horizontal plane P as the distal tip of the reagent compartment or less than 8 mm away from the open distal end of the cap body in an initial state, such that when the female or male Luer connector engages the device, the reagent compartment is compressed and retracts toward the proximal wall.

[0029] In one or more embodiments, compression of the chamber releases a disinfectant or antimicrobial agent from the reagent compartment to disinfect the female or male Luer connector. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzalkonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

[0030] In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or gel.

[0031] In one or more embodiments, the female luer connector is selected from the group comprising essentially a needleless connector, a stopcock, and a hemodialysis connector.

[0032] In one or more embodiments, the male connector is an intravenous tubing end or a stopcock.

[0033] In one or more embodiments, the device further includes a peelable seal at the open end of the cap body.

[0034] In one or more embodiments, the peelable seal may include an aluminum or multi-layer polymeric film peel top.

[0035] According to a third exemplary embodiment of the present disclosure, the device generally comprises a cap body, a coupling cylinder, a valve compartment, a reagent compartment, and a passageway connecting the valve compartment to the reagent compartment. The reagent compartment defines a chamber containing a disinfectant or antimicrobial agent. The reagent compartment includes an outer wall surface, an inner wall surface, an array of resealable pores tightly integrated into the outer and inner wall surfaces of the reagent compartment, a permeable membrane disposed between the outer and inner wall surfaces of the reagent compartment, and a distal end.

[0036] The cap body includes a sidewall having an outer surface and an inner surface, an open distal end, and a proximal end. The sidewall has a length LO1 extending from the proximal end to the open distal end. The open end defines an end face.

[0037] In one or more embodiments, the coupling cylinder includes a sidewall with an inner surface that mates with the external threaded surface of the female connector or hemodialysis connector, an outer surface that mates with the threaded surface of the collar of the male connector, a distal end, and a proximal end.

[0038] In one or more embodiments, the valve compartment is filled with air.

[0039] In one or more embodiments, the passageway is disposed in an opening in the proximal wall.

[0040] In one or more embodiments, the distal end of the coupling cylinder includes an O-ring. In one or more embodiments, the O-ring is made of an elastomeric material.

[0041] In one or more embodiments, the side wall of the coupling cylinder includes one or more leaf springs.

[0042] In one or more embodiments, the open distal end of the cap body lies on approximately the same horizontal plane P as the distal tip of the initial reagent compartment.

[0043] In one or more embodiments, when a female or male Luer connector engages a device of the present disclosure, the reagent compartment is compressed, causing the reagent compartment to retract towards the proximal wall.

[0044] In one or more embodiments, compression of the chamber releases a disinfectant or antimicrobial agent from the reagent compartment to disinfect the female or male Luer connector. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzalkonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

[0045] In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or gel.

[0046] In one or more embodiments, the female luer connector is selected from the group consisting of an essentially needleless connector, a stopcock, and a hemodialysis connector.

[0047] In one or more embodiments, the male connector is an intravenous tubing end or a stopcock.

[0048] In one or more embodiments, the device further comprises a peelable seal at the open end of the cap body, hi one or more embodiments, the peelable seal comprises an aluminum or multilayer polymer film peel top.

[0049] According to a fourth exemplary embodiment of the present disclosure, the device generally comprises a cap body, a coupling cylinder having a sidewall made of a thin sheet of metal, a valve compartment, a reagent compartment, and a passageway connecting the valve compartment to the reagent compartment. In one or more embodiments, the passageway is disposed in an opening in the proximal wall. In one or more embodiments, the sheet metal of the coupling cylinder is perforated or meshed.

[0050] The cap body includes a sidewall having an outer surface and an inner surface, an open distal end, and a proximal end. The proximal end includes a proximal wall. In one or more embodiments, the proximal wall includes an opening. In one or more embodiments, the sidewall has a length LO1 extending from the proximal end to the open distal end. In one or more embodiments, the open distal end defines an end surface.

[0051] In one or more embodiments, the side wall of the coupling cylinder includes an inner surface that mates with the outer threaded surface of the female connector or hemodialysis connector, an outer surface that mates with the threaded surface of the collar of the male connector, a distal end, and a proximal end.

[0052] In one or more embodiments, the valve compartment is filled with air.

[0053] The reagent compartment defines a chamber containing a disinfectant or antimicrobial agent. In one or more embodiments, the reagent compartment has an exterior wall surface, an interior wall surface, an array of resealable pores tightly integrated into the exterior and interior wall surfaces of the reagent compartment, and a distal tip. [Brief description of the drawings]

[0054] [Figure 1] FIG. 1 illustrates a perspective view of a device according to a first embodiment. [Diagram 2] FIG. 2 illustrates a perspective view of a device according to a second embodiment. [Diagram 3] FIG. 3 illustrates a cross-sectional side view of the device shown in FIG. [Figure 4] FIG. 4 shows a perspective cross-sectional side view of a device according to a second embodiment. [Diagram 5] FIG. 5 illustrates a side view of a device according to a second embodiment. [Figure 6] FIG. 6 illustrates a cross-sectional side view of the device shown in FIG. [Figure 7] FIG. 7 illustrates a plan view of the device shown in FIG. [Figure 8] FIG. 8 illustrates a side view of the device shown in FIG. [Figure 9] FIG. 9 illustrates a schematic diagram of the walls of a reagent compartment of the device shown in FIG. [Figure 10] FIG. 10 illustrates a plan view of the device shown in FIG. 2 in conjunction with a closed female Luer connector according to the prior art. [Figure 11] FIG. 11 illustrates a top view of the device shown in FIG. 2 in conjunction with an open female luer connector according to the prior art. [Figure 12] FIG. 12 illustrates a plan view of the device shown in FIG. 2 in conjunction with a male Luer connector according to the prior art. [Figure 13] FIG. 13 illustrates a cross-sectional view of a device according to a third embodiment having a permeable membrane covering the boundary material of the compartment. [Figure 14] FIG. 14 illustrates a schematic diagram of the walls of the reagent compartment of the device shown in FIG. [Figure 15] FIG. 15 illustrates a schematic diagram of the walls of the reagent compartment of the device shown in FIG. [Figure 16] FIG. 16 illustrates a schematic diagram of the walls of the reagent compartment of the device shown in FIG. [Figure 17] FIG. 17 illustrates a plan view of the device shown in FIG. 13 in conjunction with a female Luer connector according to the prior art. [Figure 18] FIG. 18 illustrates a schematic diagram of the walls of the reagent compartment of the device shown in FIG. [Figure 19] FIG. 19 illustrates a plan view of the device shown in FIG. 13 in conjunction with a male Luer connector according to the prior art. [Figure 20A] FIG. 20A illustrates a perspective view of a device according to a fourth embodiment in which the coupler is a thin metal sheet. [Figure 20B] FIG. 20B illustrates a perspective view of a device according to a fourth embodiment in which the coupler is a thin metal sheet. [Figure 20C] FIG. 20C illustrates a perspective view of a device according to a fourth embodiment in which the coupler is a thin metal sheet. [Figure 20D] FIG. 20D illustrates a perspective view of a device according to a fourth embodiment in which the coupler is a thin metal sheet. [Figure 20E] FIG. 20E illustrates a perspective view of a device according to a fourth embodiment in which the coupler is a thin metal sheet. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0055] Before describing certain example embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description as being capable of other embodiments and of being practiced or carried out in various ways.

[0056] The embodiments of the present disclosure relate to a universal single-use device for connecting to and disinfecting male and female medical connectors, including male and female luer connectors. In one or more embodiments, the universal single-use device is equipped with a disinfection cap that can disinfect medical instruments such as needleless connectors, male luer connectors of intravenous lines, male luer connectors of intravenous extensions, stopcocks, and access ports, including hemodialysis connectors, while being compatible with a wide range of luer fittings, including closed female luer, open female luer, and male luer fittings. The device contains a disinfectant or antibacterial agent for disinfection. The device of the present disclosure allows practitioners to streamline the disinfection process.

[0057] The following definitions are provided for terms used in this disclosure.

[0058] As used herein, the use of "a," "an," and "the" includes the singular and plural.

[0059] As used herein, the term "catheter-related bloodstream infection" or "CRBSI" refers to any infection resulting from the presence of a catheter or IV line.

[0060] In this disclosure, the convention is followed that the distal end of the device is the end closest to the patient and the proximal end of the device is the end away from the patient and closest to the user.

[0061] The term "deformable" refers to a wall or container that is structured to be flexible enough to at least partially collapse into an interior chamber when manually depressed. The shape and extent of the deformation will vary for different configurations of the wall, container, or chamber.

[0062] As used herein, the term "Luer connector" refers to a connection collar that is a standard way of attaching syringes, catheters, hubbed needles, IV tubing, and the like to one another. The Luer connector consists of male and female interlocking tubes that are slightly tapered to better mate with even a simple press / twist fit. The Luer connector can optionally include an additional outer rim of threads, allowing the Luer connector to be more securely secured. The Luer connector male end is typically associated with a flush syringe and can interlock and connect to a female end located on a vascular access device (VAD). The Luer connector comprises a distal end, a proximal end, an irregularly shaped outer wall, and a shaped central passage for fluid communication from the chamber of the syringe barrel to the hub of the VAD. The Luer connector also has a distal end channel that removably attaches the Luer connector to the hub of the VAD, and a proximal end channel that removably attaches the Luer connector to the barrel of the syringe.

[0063] Referring to FIG. 1, the device 10 is used as a cap that is attached to a connector and can be attached to the connector for a long term. The device 10 for connecting to a medical connector according to a first exemplary embodiment of the present disclosure generally comprises a cap body 20, a coupling cylinder 30, a valve compartment 60, a reagent compartment 50, and a passageway 70 connecting the valve compartment 60 to the reagent compartment 50. The cap body 20 serves as a scaffolding for the device for mechanical support. The cap body includes a side wall 21 having an outer surface 22 and an inner surface 23, an open distal end 24, and a proximal end 25. The proximal end 25 of the cap body 20 includes a proximal wall 26 having an opening 27. In one or more embodiments, the passageway is disposed in the opening of the proximal wall.

[0064] The side wall 21 has a length L extending from the proximal end 25 to the open distal end 24. sw1 . The open end 24 defines an end surface. In one or more embodiments, as shown in FIG. 1 , the cap body 20 is cylindrical with an open cavity 29. The open cavity 29 of the cap body 20 allows access by a connector to the coupling cylinder 30 and the antimicrobial agent-containing compartment 50. The cap body 20 serves as a scaffold to which the valve compartment 60 and the reagent compartment 50 are attached. In one or more embodiments, the valve compartment 60 and the reagent compartment 50 are attached via an opening 27 located in a proximal wall 26 of the proximal end 25 of the cap body 20. The cap body 20 also serves as a mechanical barrier to prevent inadvertent compression of the reagent compartment 50. The cap body 20 is constructed of a rigid material including polypropylene, high density polyethylene (HDPE), polypropylene (PP) / thermoplastic elastomer (TPE) blend, or polyethylene (PE) / thermoplastic elastomer (TPE) blend with a layer of thermoplastic elastomer (TPE) coat, or polypropylene (PP) / polyethylene (PE) material. In one or more embodiments, the cap body may be fabricated using a two-shot molding process. In one or more embodiments, the device may further include a peelable seal at the open distal end 24 of the cap body 20. In one or more embodiments, the peelable seal may include an aluminum or multilayer polymer film peel top.

[0065] The coupling cylinder 30 is used to engage the threaded surfaces of the luer connector, including the threaded surface of a needleless connector, the threaded surface of an open female luer of a stopcock, and the threaded surface of a collar of a male connector. The coupling cylinder 30 is a cylindrical structure having a sidewall 31 with an inner surface 32 that mates with the outer threaded surface of an open or closed female connector or hemodialysis connector, and an outer surface that mates with the threaded surface of a collar of a male connector, an open distal end 34, and a proximal end 36. In one or more embodiments, the female luer connector can be a needleless connector, a stopcock, or a hemodialysis connector. In one or more embodiments, the male connector can be an intravenous tubing end or a stopcock.

[0066] The coupling cylinder may be made of semi-rigid materials such as thermoplastic elastomer (TPE), polypropylene (PP) / thermoplastic elastomer (TPE) blends, or polyethylene (PE) / thermoplastic elastomer (TPE) blends with a layer of thermoplastic elastomer (TPE) coat or other mixture of plastic and thermoplastic elastomer, thermoplastic elastomer (TPE), or rubber of similar elasticity, or polypropylene (PP) / polyethylene (PE) material. In one or more embodiments, the coupling cylinder may be made using a two-shot molding process.

[0067] In one or more embodiments, the coupling cylinder 30 is concentrically disposed within the cap body 20 and attached to the proximal end 25 of the cap body 20. The coupling cylinder 30 is a deformable, yet structurally rigid coupler that conforms to the shapes of different types of luer connectors. In one or more embodiments, the coupling cylinder 30 is made of an elastomeric material. The coupling cylinder 30 has an open cavity at its open distal end 34 on the same side as the open cavity 29 of the cap body 20.

[0068] In one or more embodiments, the open distal end 34 of the coupling cylinder 30 includes an O-ring 35. In one or more embodiments, the O-ring 35 is incorporated into the open distal end of the coupling cylinder 30 to tightly grip the connector surface. At the open end of the cavity, the rim of the cylindrical coupler forms an O-ring 35 to increase the tightness of the grip of the engagement between the coupling cylinder 30 and the connector surface. The O-ring 35 also serves the purpose of forming a seal to create a sealed space between the connector and the coupling cylinder 30. The O-ring structure 35 at the open distal end 34 of the coupling cylinder 30 can seal any liquid reagents that exit the reagent compartment when the device 10 is attached to the connector to prevent leakage of the reagents. In one or more embodiments, the O-ring 35 is made of an elastomeric material that is flexible and retains its original shape in an initial state. When a connector with the coupling cylinder 30 is inserted, the O-ring 35 expands to accommodate the connector and creates a tight seal around the connector. When the connector is removed, the O-ring 35 returns to its initial state.

[0069] In addition to the engagement of the luer, another challenge for a disinfection cap to effectively sterilize different types of connectors is the ability to conform to surfaces of different shapes, including the flat surface of a closed female luer with a central recessed septum, the cavity of an open female luer with a stopcock, and the prongs of a male luer. To achieve effective disinfection regardless of luer type, embodiments of the present disclosure have a compressible reagent compartment 50 that has the flexibility to conform to the different types of surfaces that need to be disinfected.

[0070] The reagent compartment 50 defines a chamber containing a disinfectant or antimicrobial agent. The reagent compartment 50 includes an outer wall surface 52, an inner wall surface 54, an array of resealable pores densely integrated into the outer wall surface 52 and the inner wall surface 54 of the reagent compartment 50, and a distal tip 58. The boundary material of the reagent compartment 50 has a number of densely integrated micro- or nano-sized pores 56 embedded in the polymer matrix of the reagent compartment 50 for reagent release. The boundary material of the reagent compartment sidewall 51 is perforated by densely distributed self-resealable pores. When pressure is applied to the boundary sidewall 51, the pores 56 are opened. Such opening of the pores 56 is reversible. The reagent compartment 50 is activatable by compressing a valve compartment 60 that protrudes above the cap body 20. When the valve compartment 60 is squeezed, the increased pressure from the compressed air exerts a force on the disinfectant or antimicrobial agent in the reagent compartment 50, resulting in the disinfectant or antimicrobial agent being released through the micro- or nano-sized pores 56 embedded in the polymer matrix of the reagent compartment 50. In one or more embodiments, the open distal end 24 of the cap body 20 is positioned approximately on the same horizontal plane P as the distal tip 58 of the reagent compartment 50 or less than 8 mm away from the open distal end of the cap body in an initial state, such that when the female or male Luer connector engages the device 10, the reagent compartment 50 is compressed and retracts toward the proximal wall 26. The reagent compartment 50 is constructed from a reversibly deformable material assembled onto the cap body 20 that fits a male or female Luer connector, holds a large volume of disinfectant or antimicrobial agent, releases the disinfectant or antimicrobial agent in a controllable manner, seals off the released disinfectant or antimicrobial agent for a limited interval, and mitigates intrusion by blocking the fluid path. In one or more embodiments, the reagent compartment 50 is made of an elastomeric material.

[0071] The reagent compartment 50 contains a disinfectant or antibacterial agent and has the ability to release the disinfectant or antibacterial agent when compressed. The reagent compartment 50 takes the form of a cylinder with a conical distal tip and constitutes a lower compressible compartment surrounded by the coupling cylinder 30. The reagent compartment 50 can function as a protrusion inserted into an open female Luer connector, while having the ability to retract when compressed against the protrusions of the closed female Luer connector and male Luer connector. In one or more embodiments, the reagent compartment 50 is pre-filled or pre-loaded with the disinfectant or antibacterial agent. In one or more embodiments, the reagent compartment 50 is connected to the valve compartment 60. In one or more embodiments, the interface material of the reagent compartment 50 and the valve compartment 60 is composed of an elastic material, such as an elastomer (e.g., a thermoplastic elastomer).

[0072] In one or more embodiments, either or both of the reagent compartment 50 and the valve compartment 60 can be compressed to apply pressure to the disinfectant or antimicrobial agent to facilitate release of the disinfectant or antimicrobial agent. The reagent compartment 50 is also compressible and automatically deforms upon attachment of the device 10 to a male or female connector to conform to the shape of different types of male or female connectors. In one or more embodiments, the valve compartment 60 is made of an elastomeric material. In one or more embodiments, compression of the reagent compartment 50 releases the disinfectant or antimicrobial agent from the reagent compartment 50 to disinfect the female or male Luer connector.

[0073] When pressure is removed, due to the elastic properties of the interface material, the pores automatically reseal themselves and recreate a barrier to prevent the disinfectant or antimicrobial agent from leaking out of the reagent compartment 50. The distal tip of the reagent compartment functions as a flow path blocker to block the entry of the antimicrobial agent when pressed against the inlet port of the male luer connector when the device 10 is attached to the male connector. In one or more embodiments, the distal tip of the reagent compartment 50 is conical and rigidly constructed of an elastomeric material to block the fluid path. The distal tip of the reagent compartment provides a mechanism to block the fluid path of the closed female and male connectors to prevent the disinfectant or antimicrobial agent from entering the lumen of the respective female or male connector. In one or more embodiments, the reagent compartment 50 can be inserted into the lumen of a stopcock. The outer diameter of the distal tip of the reagent compartment 50 is compatible with the outer diameter of the open female luer connector. The distal end 58 can be compressed with a male luer connector and a closed female luer connector. Upon compression, the enclosed disinfectant or antimicrobial agent retracts into the valve compartment 60.

[0074] As will be discussed in detail later in this disclosure, the embodiments of the device of the present disclosure allow for disinfection applicable to various connectors. When the device 10 is attached to a closed female luer on a needleless connector or hemodialysis connector, the reagent compartment 50 is compressed against the end face of the connector or the surface of a septum embedded in the connector. Such compression increases pressure within the compartment, which results in the release of a disinfectant or antibacterial agent to disinfect the end face of the needleless connector and the threads of the luer. When the device 10 is attached to an open female luer, such as a stopcock, the reagent compartment 50 having a shape similar to a male luer can be complementary inserted into the open luer. The disinfectant or antibacterial agent can be released into the lumen of the stopcock by compressing the valve compartment 60. When the cap is attached to the male connector, the fluid path blocking distal tip at the end of the reagent compartment 50 contacts the luer port and blocks the port inlet, preventing the subsequently released disinfectant or antibacterial agent from accessing the lumen, i.e., mitigating the entry of the disinfectant or antibacterial agent. Compression of the reagent compartment 50 against the male luer results in the release of an antimicrobial agent for disinfection.

[0075] When the reagent compartment 50 deforms or the valve compartment 60 compresses, pressure is applied to the disinfectant or antimicrobial agent, which results in the disinfectant or antimicrobial agent flowing out of the reagent compartment into the extra-compartment area 59, disinfecting the surface of the connector to which the device 10 is connected. The disinfectant or antimicrobial agent can be retained in the extra-compartment space 59 by the O-ring seal 35. The reagent compartment 50 also has a sealing component at the forward end to give it the ability to block the fluid path to avoid the ingress of the antimicrobial reagent. In one or more embodiments, the device has one open cavity and has a coupling mechanism that automatically fits different types of connectors with a simple attachment action. The compartment preloaded with the antimicrobial agent can be deformed to fit the different shapes of different types of connectors. The release of the antimicrobial agent can be controlled by the deformation of either the reagent compartment 50 or the compressible valve compartment 60. The released but retained disinfectant or antimicrobial agent can disinfect the connector port for an extended period of time.

[0076] The reagent compartment 50 is designed to be compatible in interacting with various disinfectants or antimicrobial agents. In one or more embodiments, the disinfectants or antimicrobial agents may include various alcohols or chlorhexidine. The disinfectants or antimicrobial agents may be a fluid or gel selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. The reagent fills the reagent-containing compartment 50, which constitutes a lower compartment partially surrounded by the coupling cylinder 30, while the upper portion of the antimicrobial reagent-containing compartment 50 remains filled with air. The antimicrobial reagent-containing compartment 50 is constructed of a stretchable material, such as an elastomer (e.g., a thermoplastic elastomer).

[0077] In one or more embodiments, the reagent compartment 50 contains both air and liquid reagent such that compression by the force of the valve compartment 60 or compression of the elastomeric material of the reagent compartment 50 during insertion of a male or female connector exerts air pressure on the liquid disinfectant or antimicrobial agent in the reagent compartment, opening pores and releasing the antimicrobial reagent.

[0078] In one or more embodiments, the compressible valve compartment 60 protrudes above the cap body 20, as shown in FIG. 1. In one or more embodiments, the valve compartment is filled with air or gas, and the valve compartment 60 is connected to the reagent compartment 50. When the reagent compartment 50 is compressed, the pressure in the valve compartment 60 increases, resulting in the release of the disinfectant or antibacterial agent from the reagent compartment 50. The degree of the pressure increase is determined by the elasticity of the interface materials of the reagent compartment 50 and the valve compartment 60. The valve compartment 60 also provides additional control to regulate the pressure in the reagent compartment 50 and the valve compartment 60. Manual compression of the valve compartment 60 allows for additional release of the disinfectant or antibacterial agent from the reagent compartment 50 to disinfect the connector. In one or more embodiments, the valve compartment 60 is made of an elastomeric material.

[0079] In one or more embodiments, the coupling cylinder 30, the reagent compartment 50, and the valve compartment 60 may be mechanically connected and formed as a single entity, as shown in Figure 1. In one or more embodiments, the interface between the valve compartment 60 and the reagent compartment 50 may be joined by ultrasonic welding or adhesive. In alternative embodiments, the coupling cylinder 30, the reagent compartment 50, and the valve compartment 60 constitute three structurally distinct components.

[0080] The embodiments of the device 10 of the present disclosure are self-adaptive to different types of luer connectors due to the deformable coupling cylinder 30 that can form a seal with both male and female luer connectors. The device 10 can also deform the shape of the reagent compartment 50 to accommodate both male connectors, closed female connectors, and open female connectors, achieving effective disinfection not only on the exterior surface of the luer, but also in the lumen of the open female luer.

[0081] In one or more embodiments, a removable seal is attached to the open end of the cap body to maintain sterility of the distal tip, the interior cavity, and the open distal end.

[0082] 2-8, the device 10 can be used as a cap to be attached to a connector and can be attached to the connector for a long term period. The device 10 for connecting to a medical connector according to a first exemplary embodiment of the present disclosure generally comprises a cap body 20, a coupling cylinder 30, a valve compartment 60, a reagent compartment 50, and a passageway 70 connecting the valve compartment 60 to the reagent compartment 50. The cap body 20 serves as a scaffolding for the device for mechanical support. The cap body includes a side wall 21 having an outer surface 22 and an inner surface 23, an open distal end 24, and a proximal end 25. The proximal end 25 of the cap body 20 includes a proximal wall 26 having an opening 27. In one or more embodiments, the passageway is disposed in the opening in the proximal wall.

[0083] The side wall 21 has a length Lsw that extends from the proximal end 25 to the open distal end 24. The open end 24 defines an end face. In one or more embodiments, the cap body 20 is cylindrical with an open cavity 29, as shown in Figures 2-4. The open cavity 29 of the cap body 20 allows access by a connector to the coupling cylinder 30 and the antimicrobial-containing compartment 50, as shown in Figures 10-13. The cap body 20 serves as a scaffold to which the valve compartment 60 and the reagent compartment 50 are attached. In one or more embodiments, the valve compartment 60 and the reagent compartment 50 are attached via an opening 27 located in the proximal wall 26 of the proximal end 25 of the cap body 20. The cap body 20 also serves as a mechanical barrier to prevent inadvertent compression of the reagent compartment 50. The cap body 20 is constructed of a rigid material including polypropylene, high density polyethylene (HDPE), polypropylene (PP) / thermoplastic elastomer (TPE) blend, or polyethylene (PE) / thermoplastic elastomer (TPE) blend with a layer of thermoplastic elastomer (TPE) coat, or polypropylene (PP) / polyethylene (PE) material. In one or more embodiments, the cap body may be fabricated using a two-shot molding process. In one or more embodiments, the device may further include a peelable seal at the open distal end 24 of the cap body 20. In one or more embodiments, the peelable seal may include an aluminum or multilayer polymer film peel top.

[0084] The coupling cylinder may be made of semi-rigid materials such as thermoplastic elastomer (TPE), polypropylene (PP) / thermoplastic elastomer (TPE) blends, or polyethylene (PE) / thermoplastic elastomer (TPE) blends with a layer of thermoplastic elastomer (TPE) coat or other mixture of plastic and thermoplastic elastomer, thermoplastic elastomer (TPE), or rubber of similar elasticity, or polypropylene (PP) / polyethylene (PE) material. In one or more embodiments, the coupling cylinder may be made using a two-shot molding process.

[0085] The coupling cylinder 30 is used to engage the threaded surfaces of the luer connector, including the threaded surface of a needleless connector, the threaded surface of an open female luer of a stopcock, and the threaded surface of a collar of a male connector. The coupling cylinder 30 is a cylindrical structure having a sidewall 31 with an inner surface 32 that mates with the outer threaded surface of an open or closed female connector or hemodialysis connector, and an outer surface 33 that mates with the threaded surface of a collar of a male connector, an open distal end 34, and a proximal end 36. In one or more embodiments, the female luer connector can be a needleless connector, a stopcock, or a hemodialysis connector. In one or more embodiments, the male connector can be an intravenous tubing end or a stopcock.

[0086] In one or more embodiments, the coupling cylinder 30 is concentrically disposed within the cap body 20 and attached to the proximal end 25 of the cap body 20. The coupling cylinder 30 is a deformable but structurally rigid coupler that conforms to the shape of different types of luer connectors. In one or more embodiments, the coupling cylinder 30 is made of an elastomeric material. The coupling cylinder 30 has an open cavity at the open distal end 34 on the same side as the open cavity 29 of the cap body 20. In one or more embodiments, the coupling cylinder 30 is constructed of a structure that combines the flexibility of an elastomer and the rigidity of a metallic material, providing the ability for geometric compliance to different types of connectors while maintaining a firm grip on the connector for extended periods of disinfection. In one or more embodiments, one or more leaf springs 40 are incorporated into the sidewall 31 of the coupling cylinder 30 to provide mechanical strength to maintain the original form of the sealing coupling cylinder 30 when attached to a male or female connector and to react to the deforming forces applied by the connector. The leaf springs 40 may be embedded in the material of the sidewall 31 of the coupling cylinder 30, embedded in grooves in the material of the sidewall 31 of the coupling cylinder 30, inserted during molding, or attached to the sidewall 31 of the coupling cylinder 30 via adhesive. In one or more embodiments, the leaf springs 40 are embedded longitudinally in the thin sidewall 31 of the coupling cylinder 30 to provide rigidity and structural strength to maintain the geometric integrity of the coupler when the cap is attached to the threaded surface of the connector. The leaf springs 40 can be made of a rigid but deformable material, including a thin sheet of stainless steel or a metal alloy. The leaf springs 40 can be in the form of a rectangle with a high geometric aspect ratio. An array of four to six leaf springs 40 can be embedded in the wall of the coupling cylinder 30 with equal angular spread, and the array can be axisymmetric about the central axis of the coupling cylinder 30.

[0087] In one or more embodiments, the open distal end 34 of the coupling cylinder 30 includes an O-ring 35. In one or more embodiments, the O-ring 35 is incorporated into the open distal end of the coupling cylinder 30 to tightly grip the connector surface. At the open end of the cavity, the rim of the cylindrical coupler forms an O-ring 35 to increase the tightness of the grip of the engagement between the coupling cylinder 30 and the connector surface. The O-ring 35 also serves the purpose of forming a seal to create a sealed space between the connector and the coupling cylinder 30. The O-ring structure 35 at the open distal end 34 of the coupling cylinder 30 can seal any liquid reagents that exit the reagent compartment when the device 10 is attached to the connector to prevent leakage of the reagents. In one or more embodiments, the O-ring 35 is made of an elastomeric material that is flexible and retains its original shape in an initial state. When a connector with the coupling cylinder 30 is inserted, the O-ring 35 expands to accommodate the connector and creates a tight seal around the connector. When the connector is removed, the O-ring 35 returns to its initial state.

[0088] In addition to the engagement of the luer, another challenge for a disinfection cap to effectively sterilize different types of connectors is the ability to conform to surfaces of different shapes, including the flat surface of a closed female luer with a central recessed septum, the cavity of an open female luer with a stopcock, and the prongs of a male luer. To achieve effective disinfection regardless of luer type, embodiments of the present disclosure have a compressible reagent compartment 50 that has the flexibility to conform to the different types of surfaces that need to be disinfected.

[0089] The reagent compartment 50 defines a chamber containing a disinfectant or antimicrobial agent. The reagent compartment 50 includes an outer wall surface 52, an inner wall surface 54, an array of resealable pores 56 densely integrated into the outer wall surface 52 and the inner wall surface 54 of the reagent compartment 50, and a distal tip 58. The boundary material of the reagent compartment 50 has a number of densely integrated micro- or nano-sized pores 56 embedded in the polymer matrix of the reagent compartment 50 for reagent release. The boundary material of the reagent compartment sidewall 51 is perforated by densely distributed self-resealable pores. When pressure is applied to the boundary sidewall 51, the pores 56 are opened, as shown in FIGS. 8-9. Such opening of the pores 56 is reversible. The reagent compartment 50 is activatable by compressing a valve compartment 60 that protrudes above the cap body 20. When the valve compartment 60 is squeezed, the increased pressure from the compressed air exerts a force on the disinfectant or antimicrobial agent in the reagent compartment 50, resulting in the release of the disinfectant or antimicrobial agent through micro- or nano-sized pores 56 embedded in the polymer matrix of the reagent compartment 50. In one or more embodiments, the open distal end 24 of the cap body 20 is initially positioned on approximately the same horizontal plane P as the distal tip 58 of the reagent compartment 50, whereupon the female or male Luer connector is engaged with the device 10, compressing the reagent compartment 50 and causing the reagent compartment 50 to retract toward the proximal wall 26. The reagent compartment 50 is comprised of a reversibly deformable material assembled on the cap body 20 that fits the male or female Luer connector, and functions to hold a large volume of the disinfectant or antimicrobial agent, release the disinfectant or antimicrobial agent in a controllable manner, seal the released disinfectant or antimicrobial agent for a limited interval, and mitigate intrusion by blocking a fluid pathway. In one or more embodiments, the reagent compartment 50 is made from an elastomeric material.

[0090] As shown in Figs. 9-12, the reagent compartment 50 containing the disinfectant or antibacterial agent has the ability to release the disinfectant or antibacterial agent when compressed. The reagent compartment 50 takes the form of a cylinder with a conical distal tip 58 and constitutes a lower compressible compartment surrounded by the coupling cylinder 30. The reagent compartment 50 can function as a protrusion to be inserted into an open female Luer connector, while having the ability to retract when compressed against the protrusions of the closed female Luer connector and the male Luer connector. In one or more embodiments, the reagent compartment 50 is pre-filled or pre-loaded with the disinfectant or antibacterial agent. In one or more embodiments, the reagent compartment 50 is connected to the valve compartment 60. In one or more embodiments, the interface material of the reagent compartment 50 and the valve compartment 60 is composed of an elastic material such as an elastomer (e.g., a thermoplastic elastomer).

[0091] In one or more embodiments, either or both of the reagent compartment 50 and the valve compartment 60 can be compressed to apply pressure to the disinfectant or antimicrobial agent to facilitate release of the disinfectant or antimicrobial agent. The reagent compartment 50 is also compressible and automatically deforms upon attachment of the device 10 to a male or female connector to conform to the shape of different types of male or female connectors. In one or more embodiments, the valve compartment 60 is made of an elastomeric material. In one or more embodiments, compression of the reagent compartment 50 releases the disinfectant or antimicrobial agent from the reagent compartment 50 to disinfect the female or male Luer connector.

[0092] As shown in FIG. 9, when pressure is removed, due to the elastic properties of the interface material, the pores 56 automatically reseal themselves and recreate a barrier to prevent the disinfectant or antimicrobial agent from leaking out of the reagent compartment 50 as shown in FIGS. 8-9. The distal end 58 functions as a fluid path blocker to block the entry of the antimicrobial agent when pressed against the inlet port of the male Luer connector during attachment of the device 10 to the male connector. The distal tip 58 of the reagent compartment 50 is conical and rigidly constructed of an elastomeric material to block the fluid path as shown in FIGS. 10-12. The distal tip 58 provides a mechanism to block the flow path in the closed female and male connectors to prevent the entry of the disinfectant or antimicrobial agent into the lumen of the respective female or male connector. In one or more embodiments, the reagent compartment 50 can be inserted into the lumen of a stopcock. The outer diameter of the distal tip of the reagent compartment 50 is compatible with the outer diameter of the open female Luer connector. The distal end 58 can be compressed with a male luer connector and a closed female luer connector. Upon compression, the enclosed disinfectant or antimicrobial agent retracts into the valve compartment 60.

[0093] The disclosed device embodiments allow for applicable disinfection of various connectors. As shown in FIG. 10, when the device 10 is attached to a closed female luer on a needleless connector or hemodialysis connector, the reagent compartment 50 is compressed against the end face of the connector or the surface of a septum embedded in the connector. Such compression increases pressure within the compartment, which results in the release of a disinfectant or antibacterial agent to disinfect the end face of the needleless connector and the threads of the luer, as shown in FIG. 10. As shown in FIG. 11, when the device 10 is attached to an open female luer such as a stopcock, the reagent compartment 50, which has a shape similar to a male luer, can be complementary inserted into the open luer. The disinfectant or antibacterial agent can be released into the lumen of the stopcock by compressing the valve compartment 60, as shown in FIG. 11. When the cap is attached to the male connector, the fluid path blocking distal tip 58 at the end of the reagent compartment 50 contacts the luer port and blocks the port inlet, preventing the disinfectant or antimicrobial agent to be subsequently released from accessing the lumen, i.e., mitigating disinfectant or antimicrobial ingress, as shown in Figure 12. Compression of the reagent compartment 50 against the male luer results in the release of the disinfectant antimicrobial agent, as shown in Figure 12.

[0094] When the reagent compartment 50 deforms or the valve compartment 60 compresses, pressure is applied to the disinfectant or antimicrobial agent, which results in the disinfectant or antimicrobial agent flowing out of the reagent compartment into the extra-compartment area 59, disinfecting the surface of the connector to which the device 10 is connected. The disinfectant or antimicrobial agent can be retained in the extra-compartment space 59 by the O-ring seal 35. The reagent compartment 50 also has a sealing component at the forward end to give it the ability to block the fluid path to avoid the ingress of the antimicrobial reagent. In one or more embodiments, the device has one open cavity and has a coupling mechanism that automatically fits different types of connectors with a simple attachment action. The compartment preloaded with the antimicrobial agent can be deformed to fit the different shapes of different types of connectors. The release of the antimicrobial agent can be controlled by the deformation of either the reagent compartment 50 or the compressible valve compartment 60. The released but retained disinfectant or antimicrobial agent can disinfect the connector port for an extended period of time.

[0095] The reagent compartment 50 is designed to be compatible in interacting with various disinfectants or antimicrobial agents. In one or more embodiments, the disinfectants or antimicrobial agents may include various alcohols or chlorhexidine. The disinfectants or antimicrobial agents can be a fluid or gel selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. The reagent fills the reagent-containing compartment 50, which constitutes a lower compartment partially enclosed by the coupling cylinder 30, while the upper portion of the antimicrobial reagent-containing compartment 50 remains filled with air. The antimicrobial reagent-containing compartment 50 is constructed of a stretchable material, such as an elastomer (e.g., a thermoplastic elastomer).

[0096] In one or more embodiments, the reagent compartment 50 contains both air and liquid reagent such that compression by the force of the valve compartment 60 or compression of the elastomeric material of the reagent compartment 50 during insertion of a male or female connector exerts air pressure on the liquid disinfectant or antimicrobial agent in the reagent compartment, opening pores and releasing the antimicrobial reagent.

[0097] In one or more embodiments, the compressible valve compartment 60 protrudes above the cap body 20. In one or more embodiments, as shown in Figs. 2-8, the valve compartment is filled with air or gas, and the valve compartment 60 is connected to the reagent compartment 50. When the reagent compartment 50 is compressed, the pressure in the valve compartment 60 increases, resulting in the release of the disinfectant or antibacterial agent from the reagent compartment 50. The degree of the pressure increase is determined by the elasticity of the interface materials of the reagent compartment 50 and the valve compartment 60. The valve compartment 60 also provides additional control to regulate the pressure in the reagent compartment 50 and the valve compartment 60. Manual compression of the valve compartment 60 can additionally release the disinfectant or antibacterial agent from the reagent compartment 50 to disinfect the connector. In one or more embodiments, the valve compartment 60 is made of an elastomeric material. As shown in FIGS. 2-8, the valve compartment 60 can include a thumb press 61 located at the proximal end of the device that can be manually depressed in the direction indicated by arrow "A" in FIG.

[0098] In one or more embodiments, the coupling cylinder 30, the reagent compartment 50, and the valve compartment 60 may be mechanically connected and formed as a single entity, as shown in Figure 8. In one or more embodiments, the interface between the valve compartment 60 and the reagent compartment 50 may be joined by ultrasonic welding or adhesive. In alternative embodiments, the coupling cylinder 30, the reagent compartment 50, and the valve compartment 60 constitute three structurally distinct components.

[0099] The embodiments of the device 10 of the present disclosure are self-adaptive to different types of luer connectors due to the deformable coupling cylinder 30 that can form a seal with both male and female luer connectors. The device 10 can also deform the shape of the reagent compartment 50 to accommodate both male connectors, closed female connectors, and open female connectors, achieving effective disinfection not only on the exterior surface of the luer, but also in the lumen of the open female luer.

[0100] In one or more embodiments, a removable seal is attached to the open end of the cap body to maintain sterility of the distal tip 58, the interior cavity, and the open distal end.

[0101] As shown in FIG. 13, an alternative embodiment of the present disclosure relates to an alternative mechanism of release of a disinfectant or antimicrobial reagent. As shown in FIG. 13, the device 100 includes a cap body 120, a coupling cylinder 130, a valve compartment 160, a reagent compartment 150, and a passageway 170 connecting the valve compartment 160 to the reagent compartment 150. The side wall 121 has an outer surface 122 and an inner surface 123, an open distal end 124, and a proximal end 125. The proximal end 125 of the cap body 120 includes a proximal wall 126 having an opening 127. In one or more embodiments, the passageway is disposed in the opening of the proximal wall. In one or more embodiments, the valve compartment 160 and the reagent compartment 150 are attached via an opening 127 disposed in the proximal wall 126 of the proximal end 125 of the cap body 120. The cap body 120 also functions as a mechanical barrier to prevent inadvertent compression of the reagent compartment 150. The cap body 120 is constructed of a rigid material including polypropylene, high density polyethylene (HDPE), polypropylene (PP) / thermoplastic elastomer (TPE) blend, or polyethylene (PE) / thermoplastic elastomer (TPE) blend with a layer of thermoplastic elastomer (TPE) coat, or polypropylene (PP) / polyethylene (PE) material. In one or more embodiments, the cap body may be fabricated using a two-shot molding process.

[0102] The sidewall 121 has a length Lsw that extends from a proximal end 125 to an open distal end 124. The open distal end 124 defines an end face.

[0103] The coupling cylinder may be made of a semi-rigid material such as a thermoplastic elastomer (TPE), a polypropylene (PP) / thermoplastic elastomer (TPE) blend, or a polyethylene (PE) / thermoplastic elastomer (TPE) blend, or a polypropylene (PP) / polyethylene (PE) material with a layer of a thermoplastic elastomer (TPE) coat or other mixture of plastic and thermoplastic elastomer, thermoplastic elastomer (TPE), or rubber of similar elasticity. In one or more embodiments, the coupling cylinder may be made using a two-shot molding process.

[0104] The coupling cylinder 130 is used to engage the threaded surfaces of the luer connector, including the threaded surface of a needleless connector, the threaded surface of an open female luer of a stopcock, and the threaded surface of a collar of a male connector. The coupling cylinder 130 is a cylindrical structure having a sidewall 131 with an inner surface 132 that mates with the outer threaded surface of an open or closed female connector or hemodialysis connector, and an outer surface 133 that mates with the threaded surface of a collar of a male connector, an open distal end 134, and a proximal end 136. In one or more embodiments, the female luer connector can be a needleless connector, a stopcock, or a hemodialysis connector. In one or more embodiments, the male connector can be an intravenous tubing end or a stopcock.

[0105] The reagent compartment 150 defines a chamber containing a disinfectant or antimicrobial agent. The reagent compartment 150 includes an exterior wall surface 152, an interior wall surface 154, an array of resealable pores 156 tightly integrated into the exterior wall surface 152 and the interior wall surface 154 of the reagent compartment 150, and a sidewall 151 having a distal portion, and a distal end 158. A permeable membrane 155 is disposed between the exterior wall surface 152 and the interior wall surface 154 of the reagent compartment 150.

[0106] The passageway 128 connects the valve compartment 160 to the reagent compartment 150. In one or more embodiments, the passageway 128 is disposed in an opening 127 in the proximal wall 126.

[0107] The sidewall 151 of the reagent compartment 150 is perforated by densely distributed micro- or nano-sized pores 156 tightly integrated into the outer wall surface 152 and the inner wall surface 154 of the reagent compartment 150. The pores 156 are covered by a layer of permeable membrane 155 which may form a separate layer attached to the inner wall surface 154 of the reagent compartment or may be embedded into the cylindrical sidewall 151 as an integral material. The combination of the permeable membrane 155 and the pores 156 allows for the distribution of a disinfectant or antimicrobial agent when the pressure within the reagent compartment 150 increases above a threshold value, as shown in Figures 14-19. The permeable membrane 155 adds an additional mechanism for controlling the release rate of the disinfectant or antimicrobial agent, since the threshold pressure can be determined by adjusting the permeability of the permeable membrane material. For example, the threshold value can be adjusted high enough so that the antimicrobial agent is not activated until the valve compartment is manually compressed, as shown in Figures 17-19.

[0108] The permeable membrane 155 is composed of a material with holes that are not completely removed, so that when pressure is applied, the pores 156 open up. The pores 156 are micron holes coated by a layer of permeable membrane 155 with very small scale wrinkles through which the liquid disinfectant or antibacterial agent can penetrate. In one or more embodiments, the micron holes of the pores 156 are on the scale of 100 microns. In one or more embodiments, the micron holes of the pores 156 are on the scale of 100 nanometers. In one or more embodiments, after the pressure is removed, the holes of the pores 156 remain open, creating actual channels and are not resealable. In one or more embodiments, the pores are covered with a fiber mesh or filter material. In one or more embodiments, the permeable membrane after pressure is applied forms a barrier because the liquid penetrates without pressure and the small pore membrane is covered with a fiber mesh or filter material.

[0109] The boundary material of the reagent compartment 150 has a large number of micro- or nano-sized pores 156 embedded in a polymer matrix. A permeable membrane 155 is either attached to the compartment boundary as a separate layer or embedded in the boundary material and acts as a barrier to prevent leakage of the enclosed liquid. In one or more embodiments, the permeable membrane has pores smaller than those of the reagent compartment material, as shown in FIG. 15. In one or more embodiments, the permeable membrane 155 is bonded onto the reagent compartment 150. The permeable membrane 155 comprises smaller sized pores 156 (nanopores) or a thin layer of deposited material that is permeable to water.

[0110] In one or more embodiments, the compressible valve compartment 160 protrudes above the cap body 120. In one or more embodiments, as shown in FIG. 13, the valve compartment is filled with air or gas, and the valve compartment 160 is connected to the reagent compartment 150. When the reagent compartment 150 is compressed, the pressure in the valve compartment 160 increases, resulting in the release of the disinfectant or antibacterial agent from the reagent compartment 150. The degree of pressure increase is determined by the elasticity of the boundary materials of the side walls and permeable membranes of the reagent compartment 150 and the valve compartment 160. The valve compartment 160 also provides additional control to regulate the pressure in the reagent compartment 150 and the valve compartment 160. Manual compression of the valve compartment 160 can additionally release the disinfectant or antibacterial agent from the reagent compartment 150 to disinfect the connector. In one or more embodiments, the valve compartment 160 is made of an elastomeric material. As shown in FIG. 13, the valve compartment 160 can include a thumb press 161 located at the proximal end of the device that can be manually depressed in the direction indicated by arrow "A" in FIGS. 17-19.

[0111] The reagent compartment 150 is activated by compressing an upper valve compartment 160 that protrudes above the cap body 120. In one or more embodiments, the valve compartment 260 is filled with air. When the valve compartment 160 is squeezed, the increased pressure from the compression of the air exerts a force on the liquid disinfectant or antimicrobial agent in the reagent compartment 150, resulting in the release of the liquid disinfectant or antimicrobial agent through the permeable membrane 155.

[0112] The reagent compartment 150 can be inserted into the lumen of the stopcock. The outer diameter of the reagent compartment is compatible with the outer diameter of the open female luer. It can be compressed with the male luer and the closed female luer. Figures 17-18 illustrate the device shown in Figure 13 in conjunction with a prior art female luer connector. Figure 19 illustrates a top view of the device shown in Figure 13 in conjunction with a prior art male luer connector. When compressed, the enclosed fluid retreats into the valve compartment 160.

[0113] The reagent compartment 150 is designed to be compatible in interacting with various disinfectants or antimicrobial agents. In one or more embodiments, the disinfectants or antimicrobial agents may include various alcohols or chlorhexidine. The disinfectants or antimicrobial agents can be a fluid or gel selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. The reagent fills the reagent-containing compartment 150, which constitutes a lower compartment partially surrounded by the coupling cylinder 130, while the upper portion of the antimicrobial reagent-containing compartment 150 remains filled with air. In one or more embodiments, the antimicrobial reagent-containing compartment 150 is constructed from a stretchable material, such as an elastomer, e.g., a thermoplastic elastomer.

[0114] The coupling cylinder 130 is a cylindrical structure with an opening at the bottom. The inner surface matches the outer thread surface of the open or closed female connector and the hemodialysis connector. The outer surface matches the thread surface of the collar of the male connector.

[0115] In one or more embodiments, one or more leaf springs 140 are embedded in the sidewall 131 of the coupling cylinder 130 to provide mechanical strength to maintain the original form of the sealed coupling cylinder 130 when attached to a male or female connector and to react against the deforming forces applied by the connector. The leaf springs 140 can be embedded in the material of the sidewall 131 of the coupling cylinder 130, embedded in grooves in the material of the sidewall 131 of the coupling cylinder 130, inserted during molding, or attached to the sidewall 131 of the coupling cylinder 130 via adhesive. The leaf springs 140 can be made of a rigid but deformable material, including thin sheets of stainless steel or metal alloys. The leaf springs 140 can be in the form of a rectangle with a high geometric aspect ratio. An array of four to six leaf springs 140 can be embedded in the wall of the coupling cylinder 130 with equal angular spread, and the array can be axisymmetric about the central axis of the coupling cylinder 130.

[0116] The O-ring structure 135 at the open distal end 134 of the coupling cylinder 130 can seal the liquid disinfectant or antibacterial agent when the device 100 is attached to the connector to prevent leakage of the disinfectant or antibacterial agent. In one or more embodiments, the O-ring 135 is incorporated into the open distal end of the coupling cylinder 130 to grip the connector surface tightly. At the open end of the cavity, the edge of the cylindrical coupler forms the O-ring 135 to increase the tightness of the grip of the engagement between the coupling cylinder 130 and the connector surface. The O-ring 135 also serves the purpose of forming a seal to create a sealed space between the connector and the coupling cylinder 130. The O-ring structure 135 at the open distal end 134 of the coupling cylinder 130 can seal any liquid reagent that exits the reagent compartment when the device 100 is attached to the connector to prevent leakage of the reagent. In one or more embodiments, the O-ring 135 is made of an elastomeric material that is flexible and retains its original shape in the initial state. When a connector with coupling cylinder 130 is inserted, O-ring 135 expands to accommodate the connector and creates a tight seal around the connector. When the connector is removed, O-ring 135 returns to its original state.

[0117] In one or more embodiments, the open distal end 124 of the cap body 120 is initially positioned on approximately the same horizontal plane P as the distal tip 158 of the reagent compartment 150, whereupon the female or male Luer connector is engaged with the device 100, compressing the reagent compartment 150 and retracting the reagent compartment 150 toward the proximal wall 126. The distal tip 158 functions as a fluid path blocker to block the entry of antimicrobial reagents when pressed against the inlet port of the male Luer connector upon attachment of the device 10 to the male connector. The distal tip 158 of the reagent compartment 150 is conical and rigidly constructed of an elastomeric material to block the fluid path, as shown in FIGS. 17-19. The distal tip 158 provides a mechanism to block the fluid path in the closed female and male connectors to prevent the entry of disinfectants or antimicrobial agents into the lumen of the respective female or male connector. In one or more embodiments, the reagent compartment 150 can be inserted into the lumen of the stopcock. The outer diameter of the distal tip 158 of the reagent compartment 150 is compatible with the outer diameter of an open female Luer connector. The distal end 158 can be compressed with a male Luer connector and a closed female Luer connector. Upon compression, the enclosed disinfectant or antimicrobial agent retracts into the valve compartment 160.

[0118] The distal tip 158 presses against the inlet port of a male or female Luer connector to block the entry of disinfectants or antimicrobial agents when the device 100 is attached to the male or female connector.

[0119] In one or more embodiments, the valve compartment 160 and the reagent compartment 150 are attached via an opening 127 located in the proximal wall 126 of the proximal end 125 of the cap body 120. The cap body 120 also functions as a mechanical barrier to prevent inadvertent compression of the reagent compartment 150. The cap body 120 is constructed of a rigid material including polypropylene, high density polyethylene (HDPE), polypropylene (PP) / thermoplastic elastomer (TPE) blend, or polyethylene (PE) / thermoplastic elastomer (TPE) blend with a layer of thermoplastic elastomer (TPE) coat, or polypropylene (PP) / polyethylene (PE) material. In one or more embodiments, the cap body may be fabricated using a two-shot molding process.

[0120] In one or more embodiments, the coupling cylinder 130, the reagent compartment 150, and the valve compartment 160 can be mechanically connected and formed as a single entity, as shown in Figure 13. In one or more embodiments, the interface between the valve compartment 160 and the reagent compartment 150 can be joined by ultrasonic welding or adhesive. In alternative embodiments, the coupling cylinder 130, the reagent compartment 150, and the valve compartment 160 constitute three structurally distinct components.

[0121] In one or more embodiments, the device may further include a removable or peelable seal at the open distal end 124 of the cap body 120 to maintain sterility of the distal tip 158, the interior cavity, and the open distal end. In one or more embodiments, the removable or peelable seal may include an aluminum or multilayer polymeric film peel top.

[0122] As shown in Figures 20a-20e, an alternative embodiment of the present disclosure relates to an alternative mechanism for strengthening the sidewall of the coupling cylinder. As shown in Figures 20a-20b, the device 200 includes a cap body 220, a coupling cylinder 230, a valve compartment 260, a reagent compartment 250, and a passageway 270 connecting the valve compartment 260 to the reagent compartment 250. The sidewall 221 has an outer surface 222 and an inner surface 223, an open distal end 224, and a proximal end 225. The proximal end 225 of the cap body 220 includes a proximal wall 226 having an opening 227. In one or more embodiments, the passageway is disposed in an opening in the proximal wall. In one or more embodiments, the valve compartment 260 and the reagent compartment 250 are attached via an opening 227 disposed in the proximal wall 226 of the proximal end 225 of the cap body 220. The cap body 220 also functions as a mechanical barrier to prevent inadvertent compression of the reagent compartment 250. The cap body 220 is constructed of a rigid material including polypropylene, high density polyethylene (HDPE), polypropylene (PP) / thermoplastic elastomer (TPE) blend, or polyethylene (PE) / thermoplastic elastomer (TPE) blend with a layer of thermoplastic elastomer (TPE) coat, or polypropylene (PP) / polyethylene (PE) material. In one or more embodiments, the cap body may be fabricated using a two-shot molding process.

[0123] The coupling cylinder may be made of a semi-rigid material such as a thermoplastic elastomer (TPE), a polypropylene (PP) / thermoplastic elastomer (TPE) blend, or a polyethylene (PE) / thermoplastic elastomer (TPE) blend, or a polypropylene (PP) / polyethylene (PE) material with a layer of a thermoplastic elastomer (TPE) coat or other mixture of plastic and thermoplastic elastomer, thermoplastic elastomer (TPE), or rubber of similar elasticity. In one or more embodiments, the coupling cylinder may be made using a two-shot molding process.

[0124] The coupling cylinder 230 is used to engage with the threaded surfaces of luer connectors, including the threaded surfaces of needleless connectors, the threaded surfaces of female luers with stopcock openings, and the threaded surfaces of collars of male connectors. As shown in Fig. 20a and Fig. 20b, the coupling cylinder 230 is constructed from either a cylindrical thin wall formed by a metal sheet 242 as shown in Fig. 20c, or a perforated metal sheet 242 as shown in Fig. 20d, or a meshed metal sheet 242 as shown in Fig. 20e, providing a reinforcing component to the sidewall of the coupling cylinder 230. Such a thin wall reinforcing structure provides mechanical strength to the coupling cylinder 230 to maintain its geometric integrity while not completely compromising the flexibility of the coupling cylinder 230, so that the coupling cylinder 230 can still bend to conform to the connector shape to which the device 200 is attached.

[0125] The reagent compartment 250 defines a chamber containing a disinfectant or antimicrobial agent. The reagent compartment 250 includes an exterior wall surface 252, an interior wall surface 254, an array of resealable pores 256 tightly integrated into the exterior wall surface 252 and the interior wall surface 254 of the reagent compartment 250, and a sidewall 251 having a distal portion 258. In one or more embodiments, a permeable membrane 255 is disposed between the exterior wall surface 252 and the interior wall surface 254 of the reagent compartment 250. The permeable membrane 255 is either attached to the compartment boundary as a separate layer or embedded in the boundary material and functions as a barrier to prevent leakage of the enclosed liquid. In one or more embodiments, the permeable membrane has pores smaller than the pores of the reagent compartment material.

[0126] The passageway 228 connects the valve compartment 260 to the reagent compartment 250. In one or more embodiments, the passageway 228 is disposed in an opening 227 in the proximal wall 226.

[0127] The side wall 251 of the reagent compartment 250 is perforated by densely distributed micro- or nano-sized pores 256 closely integrated into the outer wall surface 252 and the inner wall surface 254 of the reagent compartment 250 .

[0128] In one or more embodiments, the reagent compartment 250 can be activated by compressing an upper valve compartment 260 that protrudes above the cap body 220. When the valve compartment 260 is squeezed, the increased pressure from the compressed air exerts a force on the reagent in the reagent compartment 250, resulting in the reagent being expelled through a side wall 251 of the reagent compartment 250.

[0129] The reagent compartment 250 can be inserted into the lumen of the stopcock. The outer diameter of the reagent compartment is compatible with the outer diameter of the open female luer. The reagent compartment can be compressed with the male luer and the closed female luer. When compressed, the enclosed fluid retreats into the valve compartment 260.

[0130] The reagent compartment 250 is designed to be compatible in interacting with various disinfectants or antimicrobial agents. In one or more embodiments, the disinfectants or antimicrobial agents may include various alcohols or chlorhexidine. The disinfectants or antimicrobial agents can be a fluid or gel selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. The reagent fills the reagent-containing compartment 150, which constitutes a lower compartment partially surrounded by the coupling cylinder 230, while the upper portion of the antimicrobial reagent-containing compartment 250 remains filled with air. In one or more embodiments, the antimicrobial reagent-containing compartment 250 is constructed from a stretchable material, such as an elastomer, e.g., a thermoplastic elastomer.

[0131] The coupling cylinder 230 is a cylindrical structure with an opening at the bottom. The inner surface matches the outer thread surface of the open or closed female connector and the hemodialysis connector. The outer surface matches the thread surface of the collar of the male connector.

[0132] The O-ring structure 235 at the open distal end 234 of the coupling cylinder 230 can seal the liquid disinfectant or antimicrobial agent when the device 100 is attached to the connector to prevent leakage of the disinfectant or antimicrobial agent. In one or more embodiments, the O-ring 235 is incorporated into the open distal end of the coupling cylinder 230 to grip the connector surface tightly. At the open end of the cavity, the edge of the cylindrical coupler forms the O-ring 235 to increase the tightness of the grip of the engagement between the coupling cylinder 230 and the connector surface. The O-ring 235 also serves the purpose of forming a seal to create a sealed space between the connector and the coupling cylinder 230. The O-ring structure 235 at the open distal end 234 of the coupling cylinder 230 can seal any liquid reagent that exits the reagent compartment when the device 200 is attached to the connector to prevent leakage of the reagent. In one or more embodiments, the O-ring 235 is made of an elastomeric material that is flexible and retains its original shape in an initial state. When a connector with coupling cylinder 230 is inserted, O-ring 235 expands to accommodate the connector and creates a tight seal around the connector. When the connector is removed, O-ring 235 returns to its original state.

[0133] In one or more embodiments, the open distal end 224 of the cap body 220 is initially positioned on approximately the same horizontal plane P as the distal tip 258 of the reagent compartment 250, whereupon the female or male Luer connector is engaged with the device 200, the reagent compartment 250 is compressed, and the reagent compartment 250 retracts toward the proximal wall 226. The distal end 258 functions as a fluid path blocker to block the entry of antimicrobial reagents when pressed against the inlet port of the male Luer connector upon attachment of the device 200 to the male connector. The distal tip 258 of the reagent compartment 250 is conical and rigidly constructed from an elastomeric material to block the fluid path. The distal tip 258 provides a mechanism to block the fluid path in the closed female and male connectors to prevent the entry of disinfectants or antimicrobial agents into the lumen of the respective female or male connector. In one or more embodiments, the reagent compartment 250 can be inserted into the lumen of the stopcock. The outer diameter of the distal tip 258 of the reagent compartment 250 is compatible with the outer diameter of an open female Luer connector. The distal end 258 can be compressed with a male Luer connector and a closed female Luer connector. Upon compression, the enclosed disinfectant or antimicrobial agent retracts into the valve compartment 260.

[0134] The distal tip 258 presses against the inlet port of a male or female Luer connector to block the entry of disinfectants or antibacterial agents when the device 200 is installed onto the male or female connector.

[0135] In one or more embodiments, the coupling cylinder 230, the reagent compartment 250, and the valve compartment 260 can be mechanically connected and formed as a single entity, as shown in Figures 20a and 20b. In one or more embodiments, the interface between the valve compartment 260 and the reagent compartment 250 can be joined by ultrasonic welding or adhesive. In alternative embodiments, the coupling cylinder 230, the reagent compartment 250, and the valve compartment 260 constitute three structurally distinct components.

[0136] In one or more embodiments, the device may further include a removable or peelable seal at the open distal end 224 of the cap body 220 to maintain sterility of the distal tip 258, the interior cavity, and the open distal end. In one or more embodiments, the removable or peelable seal may include an aluminum or multilayer polymeric film peel top.

[0137] The embodiments of the devices 10, 200 and 200 of the present disclosure take advantage of the compliance of elastomeric materials and the compressibility of the space enclosed by such elastomeric materials. The design is based on using elastomeric materials to form components that can accommodate different types of luer fittings and release antimicrobial materials for disinfection in a manner that meets the needs of the disinfection caps, and that can be used to disinfect in a manner that meets the cleaning needs of various types of luer connectors. The embodiments of the present disclosure also combine compliant materials with rigid materials to create a composite material that can be deformed to fit various shapes while maintaining structural strength to meet the needs of both the aspects of attachment to the connector and sealing the disinfection space, both preventing leakage of antimicrobial reagents and creating a mechanical barrier to reduce contamination.

[0138] In one or more embodiments, devices 10, 100, and 200 of the present disclosure may be manufactured according to injection molding or mold-and-fill techniques of a nature well understood in the art.

[0139] The concept of the form-fill-in process is that the container is continuously formed, filled, and sealed as a single container without human intervention in a sterile, enclosed area within the machine. Form-fill-in manufacturing forms a sealed container by extruding and forming a parison into a mold, filling the container, and sealing the container in a single step. This manufacturing process allows devices to be manufactured in a single process. For example, pharmaceutical grade resin is extruded into a tube, which is then formed into a valve compartment and a reagent compartment. A mandrel is inserted into the newly formed valve compartment and reagent compartment and filled. The valve compartment and reagent compartment are then sealed and mated with a cap body, all of which are in a sterile, covered chamber. The device is then discharged into a non-sterile area for packaging and distribution. This form-fill-in technique comprises the continuous extrusion through an extruder head of a length of a parison, in the form of a hollow tube between and through two cooperating first or main mold halves. The method includes cutting the parison below the extruder head and above the main mold half to create an opening, which allows a blow and fill nozzle assembly to move downward into the opening in the parison, mold and then fill the molded valve compartment and reagent compartment. Once the container portion of the container assembly is filled with a desired amount of liquid disinfectant or antimicrobial agent, the blow and fill nozzle assembly is retracted from the opening in the parison. A separate pair of cooperating second or top sealing mold halves are then moved together around the exposed length of the parison to form and seal the valve compartment top. The completed assembly, fully formed, filled and sealed as a unitary structure, is then conveyed out of the molding apparatus.

[0140] The embodiments of the present disclosure may be used with access ports including needleless connectors, male luer connectors on IV lines / extensions, open female luer on stopcocks, and hemodialysis connectors for disinfection purposes. In some embodiments, the connector comprises a needleless injection site, which may often be referred to as a needleless injection port, hub, valve, or device, or a needleless access site, port, hub, valve, or device. In one or more embodiments, the female luer connector may be a needleless connector, a stopcock, or a hemodialysis connector. In one or more embodiments, the needleless connector is selected from a Q-Syte connector, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave Clear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, and the like. In one or more embodiments, the male connector may be an intravenous tubing end or a stopcock.

[0141] In some embodiments, the presently disclosed devices 10, 100, and 200 can be connected to any of a variety of different needleless injection sites, such as those previously listed. The use of the presently disclosed devices 10, 100, and 200 replaces the standard swabbing protocol for cleaning connectors.

[0142] References throughout this specification to "one embodiment," "a particular embodiment," "one or more embodiments," or "an embodiment" mean that the particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. That is, the appearances of phrases such as "in one or more embodiments," "in a particular embodiment," "in one embodiment," or "in an embodiment" in various places throughout this specification do not necessarily refer to the same embodiment of the disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0143] Although the present disclosure has been described with reference to particular embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed method and apparatus without departing from the spirit and scope of the present invention. Therefore, the present disclosure is intended to cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. A device for connecting to a medical connector, comprising: a cap body including a sidewall having an outer surface and an inner surface, an open distal end, and a proximal end including a proximal wall, the proximal wall having an opening; a coupling cylinder located inside the cap body, the coupling cylinder having a distal end and a deformable side wall with one or more longitudinally embedded leaf springs, the coupling cylinder being capable of mating with a male connector or a female connector; a compressible, air-filled valve compartment located in the proximal wall of the cap body; a reagent compartment located inside the coupling cylinder and defining a chamber containing a disinfectant or antibacterial agent; a passageway connecting the valve compartment to the reagent compartment, the passageway being disposed in the opening in the proximal wall; Equipped with The device, wherein the reagent compartment has an exterior wall surface, an interior wall surface, an array of densely distributed automatically resealable pores integrated into the exterior and interior wall surfaces of the reagent compartment, and a distal tip.

2. The device of claim 1 , wherein the distal end of the coupling cylinder has an O-ring.

3. The device of claim 2 , wherein the O-ring is made of an elastomeric material.

4. 10. The device of claim 1, wherein the one or more leaf springs are in the form of a rectangle having a high geometric aspect ratio.

5. 2. The device of claim 1, wherein the one or more leaf springs are embedded in a side wall of the coupling cylinder with equal angular spread.

6. The device of claim 1 , wherein the one or more leaf springs are axisymmetric about a central axis of the coupling cylinder.

7. The device of claim 1 , wherein the one or more leaf springs are made from a thin sheet of stainless steel or a metal alloy.

8. The device of claim 1 , wherein the open distal end of the cap body initially lies on approximately the same horizontal plane P as the distal tip of the reagent compartment.

9. The device of claim 1 , wherein the reagent compartment is compressed and retracts toward the proximal wall when a female or male Luer connector is engaged to the device.

10. 10. The device of claim 9, wherein the compression of the reagent compartment releases the disinfectant or antimicrobial agent from the reagent compartment to disinfect the female luer connector or the male luer connector.

11. 2. The device of claim 1, wherein the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

12. The device of claim 1 , wherein the disinfectant or antimicrobial agent is a fluid or gel.

13. 10. The device of claim 1, wherein the female connector is selected from the group consisting essentially of a needleless connector, a stopcock, and a hemodialysis connector.

14. The device of claim 1 , wherein the male connector is an intravenous tubing end or a stopcock.

15. The device of claim 1 , further comprising a peelable seal at the open distal end of the cap body.

16. The device of claim 1 , further comprising a conical distal tip rigidly constructed of an elastomeric material.

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